- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01313052
Forensic Assertive Community Treatment: An Emerging Model of Service Delivery (FACT)
The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to enhanced outpatient treatment (close outpatient follow-up without judicial monitoring). Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor will be randomly assigned to each treatment group and followed for 12 months. Primary outcomes will include criminal justice and mental health service utilization rates, treatment adherence, psychiatric symptoms, substance abuse, homelessness, perceived coercion, and consumer satisfaction. Service utilization outcomes will be tracked using established mental health and criminal justice databases.
Hypotheses are:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in preventing arrest, incarceration, emergency department and inpatient hospital use among high-risk adults with psychotic disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
FACT (Forensic Assertive Community Treatment) is an adaptation of the Assertive Community Treatment (ACT) model that addresses a significant gap in our service delivery systems by targeting the interface between mental health and criminal justice services. ACT was originally developed to engage severely mentally ill adults in outpatient psychiatric treatment through the use of assertive outreach and comprehensive services. FACT adds legal leverage in the form of judicial monitoring to ACT, which is comprehensive, high intensity, mobile, psychiatric treatment.
The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to enhanced outpatient treatment (close outpatient follow-up without judicial monitoring). Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor will be randomly assigned to each treatment group and followed for 12 months. Primary outcomes will include criminal justice and mental health service utilization rates, treatment adherence, psychiatric symptoms, substance abuse, and homelessness. Service utilization outcomes will be tracked using established mental health and criminal justice databases.
Hypotheses are:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in preventing arrest, incarceration, emergency department and inpatient hospital use among high-risk adults with psychotic disorders.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
New York
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Rochester, New York, United States, 14614
- Monroe County Jail
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals diagnosed with any psychotic disorder such as Schizophrenia, Schizoaffective Disorder, Bipolar Disorder with Psychotic Features, Depressive Disorder with Psychotic Features, and Psychotic Disorder, Not Otherwise Specified.
- Individuals currently facing misdemeanor or violation charges who have not yet been sentenced.
Exclusion Criteria:
- Individuals do not have or cannot be diagnosed with a psychotic disorder.
- Individuals currently facing felony charges
- Individuals currently involved in any type of legal leverage including probation, parole, drug or mental health court supervision, Assisted Outpatient Treatment, or Criminal Procedure Law status.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Forensic Assertive Community Treatment (FACT)
Individuals in this arm will receive the services of an Assertive Community Treatment team and close supervision of a judge trained in the FACT model.
|
Individuals in this arm will receive the services of an Assertive Community Treatment team and close supervision of a judge trained in the FACT model.
|
Active Comparator: Enhanced Treatment as Usual
Individuals in this arm of the study will receive an expedited appointment at a clinic specializing in the treatment of psychotic disorders.
These individuals will receive the services of a therapist, psychiatrist, and case manager.
|
Individuals in this arm of the study will receive an expedited appointment at a clinic specializing in the treatment of psychotic disorders.
These individuals will receive the services of a therapist, psychiatrist, and case manager.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jail Recidivism
Time Frame: For the one year subjects are in the study.
|
The study will measure number of arrests, number of incarcerations, and total number of jail and/or prison days in the time frame described above.
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For the one year subjects are in the study.
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Mental Health Service Utilization
Time Frame: For the one year subjects are in the study.
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The study will measure number of hospitalizations, number of hospital days, number of emergency room visits, number of outpatient mental health visits as primary outcome measures, and treatment appointment adherence.
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For the one year subjects are in the study.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: J Steven Lamberti, MD, University of Rochester
Publications and helpful links
General Publications
- Lamberti JS, Deem A, Weisman RL, LaDuke C. The role of probation in forensic assertive community treatment. Psychiatr Serv. 2011 Apr;62(4):418-21. doi: 10.1176/ps.62.4.pss6204_0418.
- Lamberti, J., & Weisman, R. (2010). Forensic assertive community treatment: Origins, current practice, and future directions. In H. Dlugacz (Ed.), Reentry Planning for Offenders With Mental Disorders (1 ed., Vol. 1, pp. 145-169). Kingston, NJ: Civic Research Institute.
- Lamberti, JS. (2011). Legal Leverage in the Treatment of Adults With Severe Mental Illness, in Workplace Violence in Mental Health and General Health Care Settings. Pages 225 - 236. M. Privitera, editor. Jones and Bartlett, Pages 225-236.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R34MH078003-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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